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ORA Weekly Management Review

Subject:ORA Weekly Management Review

Area:Operations Management

Date Revised:April, 5 2010

PURPOSE:

This Field Management Directive (FMD) provides guidance for preparing and transmitting the Office of Regulatory Affairs (ORA) Weekly Management Submission (WMS). The WMS is submitted to ORA, Office of Regional Operations (ORO) and includes reports of field activities that are of interest to other ORA and FDA components. ORO reviews, consolidates, organizes, and disseminates the final ORA Weekly Report to field and ORAHQ management, to the Office of the Commissioner, and to the Compliance Directors at each Center. These reports support communication and improve understanding of the various, significant field activities that occur each week. The content of the ORA Weekly Report is sensitive, often including pre-decisional, confidential/trade secret, and/or emerging information. Because further disclosure may jeopardize proper response to emerging issues and conflict with existing law and policy, the Weekly Report is provided with the full understanding of the recipients that further dissemination is not permitted and that sufficient control of the information must be exercised.

PROCEDURE:

REGIONS: Following the instructions below, each Regional Food and Drug Director (RFDD), or his/her designee will send a Weekly Management Submission covering significant activities within their region to the Director, ORO with a copy to the Director, ORA Office of Executive Operations (to enable OEO to provide ORA content to FDA’s weekly report to HHS) no later than 1:00PM Eastern Time each Wednesday. If Wednesday is a holiday, the review is due by 1:00PM Eastern Time on the preceding Tuesday. If questions arise during the Headquarters review of the submission, the RFDD and DRFDD will be notified by ORAHQ and a response will be expected within 24 hours to enable the final consolidated report to issue on schedule.

ORO: The designated ORO representative will consolidate the five regional Weekly Management Submissions into one report organized by program area. The Director, ORO may also include significant field operational accomplishments performed by ORAHQ staff (e.g. Dedicated Foreign Inspection Cadres, Team Biologics Investigators, ORA National Experts) and will review the consolidated report. Upon approval, the Director, ORO will authorize dissemination of the final ORA Weekly Report to field and ORAHQ management and with informational copies sent to senior leaders in the Office of the Commissioner (including the Commissioner and Principle Deputy Commissioner) and to the Directors of Compliance in each FDA Center. This report will be sent no later than 5:00PM Eastern Time each Thursday. Due to the potential sensitivity of the information in the report (e.g. emerging issues, pre-decisional information, enforcement-related matters, etc.), further dissemination of the ORA Report outside of ORA is not permitted without the approval of the Director, ORO.

FORMAT:

Address the regional submission to the Director, Office of Regional Operations (HFC-100) with informational copies to the Director, ORA Office of Executive Operations and other informational copies within ORA at the regions’ discretion (typically to field district and lab management). Transmit the submission via electronic mail following the instructions below.

General Instructions:

Include only items of significance under the specific headings and instructions below. Exclude routine, day-to-day activities.

Include information on pending/developing enforcement actions (e.g. seizure, injunction) and non-routine advisory actions (e.g. corporate-wide WL). Report significant import alerts (e.g. new/unique IA, country-wide IA) and referrals to CBP for action on FDA’s behalf under the most relevant Program Operation. Update the initial report at relevant points of case processing and minimally upon execution of the final action.

Do not report criminal actions led by OCI but regions may indicate when a referral was made to OCI.

More routine actions should be briefly reported upon execution of the final action.

Analytical findings should only be reported in the full context of the situation, typically by the home district, and addressing each of the items here and in the Specific Instructions section below. Regions should not report analytical findings as a sole item but it is always appropriate to recognize laboratory support leading to reported actions.

Exclude the name of the employees who performed the specified activities, unless the basis of the Submission item relates to something like an employee’s recognition from an outside organization (e.g. Federal Executive Board, prestigious scientific society).

For Submissions that identify planned next steps, the field will be expected to provide subsequent submissions as needed to close out each item. Subsequent submissions can typically be less detailed than the original.

Submissions must have regional level concurrence to be submitted to ORO. When preparing and reviewing, regions should consider the internal and external stakeholders that are included in its distribution.

Submissions should not exceed five pages in length.

Specific Instructions:

Each item in the regional Submission should address the following items and should be subjected to Regional Management review prior to being sent to ORO:

Background information, sufficient to enable readers to understand the current situation, but necessarily brief. The background needed to understand the situation will vary by report. Compliance history and timelines associated with current situation will usually be relevant.

Identify the status, approximate volume of affected products (to enable an understanding of the scope), and special considerations (e.g. food for children, drugs for the military) relating to the FDA regulated product involved.

For actions relating to Item B above, be specific in the planned regulatory strategy and include information that enables readers to understand the critical thinking that resulted in the regulatory strategy. If a case is reported at a very early stage, and specific regulatory strategy is unknown, include information on the timeframes of the case and expected timeframe to reach a regulatory strategy decision.

If applicable, state whether the district is working jointly or otherwise coordinating efforts with any other regulatory partners.

If applicable, include information about any unique interest (e.g. media, congressional) in the current situation.

The headings to be used and examples of items to be covered under each heading are:

1.Hot Items and Early Alerts

1.1.Such items are typically reported more routinely under other mechanisms (e.g. Trigger Memo procedure, 08:30 Head’s Up reports, Daily ORA Situation Report for Emergency Response). However, each Weekly Submission should provide a brief summary/reference to these other reports that had been submitted since the previous Weekly Submission.

2.Action Items

2.1.Identify scientific, policy or procedural issues that may require prompt attention by headquarters. ORA headquarters will review and respond to these items and notify appropriate field managers of steps taken to resolve them. [An example of such an action item could be a question of whether analytical results should be provided to a firm in the absence of an FOI request.]

3.Program Operations

The Submission should cover the programs in the following order:

3.1. Human Foods and Cosmetics

3.2. Human Drugs

3.3. Biologics

3.4. Veterinary Drugs and Feed

3.5. Medical Devices and Radiological Health

3.6. Tobacco

Follow the instructions above for the required content of each item in the Program Operations section. The bulk of the Submission is expected to be in the Program Operations section. Each item should contain a header in the following format: DISTRICT (3-letter designation-DO) and ACTION. For example:

SEA-DO RECOMMENDS SEIZURE OF ADULTERATED DEFIBRILLATORS:

4.General/Cross-Cutting Operations

This section of the Submission is typically brief and should cover the general/cross-cutting operations in the following order:

4.1. Health Fraud (include accomplishments related to a national strategy coordinated by the agency’s health fraud coordinator or unique, but very significant accomplishments)

4.2. Public Affairs/Outreach (typically only include activities/accomplishments in this area that include significant interaction with the media or that are part of a national outreach strategy)

4.3. Interaction with Elected, Federal or State Officials Not Otherwise Covered (typically include meetings/outreach conducted locally with elected officials, significant constituent issues being addressed, or significant requests for information or testimony received locally)

4.4. Administrative Management (report significant personnel, budget, or facility-related issues that would be important to other components)

4.5. Other

Each summary should contain enough details to understand the situation but should also be succinct. Subsequent Weekly Submissions should also provide updates to previous summaries left open.

Each item summarized should contain a header in the following format: DISTRICT (3-letter designation-DO) and ACTION. For example:

NWE-DO CONDUCTS ON-AIR FOOD SAFETY INTERVIEW WITH NBC AFFILIATE:

5.Work Schedule

Describe for the week beginning on the following Monday, the work schedule for the RFDDs, DDs, and Regional Laboratory Directors (i.e., who is on duty/leave, where the person will be if on official travel, and who will be in charge during any absences.)